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IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life.
PM R. 2019 Oct 24 [Online ahead of print]PM R

Abstract

BACKGROUND

Poststroke spasticity affects motor function and the ability to perform activities of daily living, with the potential to affect quality of life (QoL) and increase caregiver burden.

OBJECTIVE

To investigate the effect of repeated incobotulinumtoxinA treatment on spasticity-associated functional disability, caregiver burden, and QoL in the 36-week open-label extension of the phase 3 PURE study (NCT01392300).

DESIGN

Open-label extension period of a prospective, double-blind, placebo-controlled, randomized, multicenter study.

SETTING

Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, United States).

PARTICIPANTS

Adults, aged 18-80 years, ≥12 months since last botulinum neurotoxin injection or entirely toxin naïve, with median poststroke upper-limb spasticity of >2 years' duration.

METHODS

Participants who completed the 12-week, double-blind main period could enter the open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb.

MAIN OUTCOME MEASURES

Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol [EQ] 5-dimensions three-level [EQ-5D-3L]).

RESULTS

The open-label extension included 296 treated patients. Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P < .0001). Carer Burden Scale scores also significantly improved from the main period baseline to the end-of-study visit (P < .05 for all caregiving activities except "applying a splint"). At the end-of-study visit, versus the main period baseline, 19.7%-33.3% of patients experienced improvements for each parameter on the EQ-5D-3L, except "mobility," with significant improvement in EQ-5D visual analog scale scores (P < .001).

CONCLUSIONS

Repeated incobotulinumtoxinA treatments at 12-week intervals in participants with chronic poststroke upper-limb spasticity resulted in significant improvements in QoL, as well as significant reductions in upper-limb functional disability and caregiver burden.

Authors+Show Affiliations

Department of Physical Medicine and Rehabilitation and Department of Neurology, Northwestern University Feinberg School of Medicine and Shirley Ryan Ability Lab, Chicago, IL.Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine, Pittsburgh, PA.Department of Neurology, Wake Forest School of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC.Design Neuroscience Center, Doral, FL.Kansas City Bone & Joint Clinic, Overland Park, KS.Department of Neurological-Psychiatric Nursing, Medical University of Gdansk, Gdansk, Poland.Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.Department of Medicine, University of Nevada at Reno, Reno, NV.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31647185

Citation

Marciniak, Christina, et al. "IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life." PM & R : the Journal of Injury, Function, and Rehabilitation, 2019.
Marciniak C, Munin MC, Brashear A, et al. IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM R. 2019.
Marciniak, C., Munin, M. C., Brashear, A., Rubin, B. S., Patel, A. T., Slawek, J., Hanschmann, A., Hiersemenzel, R., & Elovic, E. P. (2019). IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM & R : the Journal of Injury, Function, and Rehabilitation. https://doi.org/10.1002/pmrj.12265
Marciniak C, et al. IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM R. 2019 Oct 24; PubMed PMID: 31647185.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. AU - Marciniak,Christina, AU - Munin,Michael C, AU - Brashear,Allison, AU - Rubin,Bruce S, AU - Patel,Atul T, AU - Slawek,Jaroslaw, AU - Hanschmann,Angelika, AU - Hiersemenzel,Reinhard, AU - Elovic,Elie P, Y1 - 2019/10/24/ PY - 2019/03/13/received PY - 2019/10/04/accepted PY - 2019/10/28/pubmed PY - 2019/10/28/medline PY - 2019/10/25/entrez JF - PM & R : the journal of injury, function, and rehabilitation JO - PM R N2 - BACKGROUND: Poststroke spasticity affects motor function and the ability to perform activities of daily living, with the potential to affect quality of life (QoL) and increase caregiver burden. OBJECTIVE: To investigate the effect of repeated incobotulinumtoxinA treatment on spasticity-associated functional disability, caregiver burden, and QoL in the 36-week open-label extension of the phase 3 PURE study (NCT01392300). DESIGN: Open-label extension period of a prospective, double-blind, placebo-controlled, randomized, multicenter study. SETTING: Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, United States). PARTICIPANTS: Adults, aged 18-80 years, ≥12 months since last botulinum neurotoxin injection or entirely toxin naïve, with median poststroke upper-limb spasticity of >2 years' duration. METHODS: Participants who completed the 12-week, double-blind main period could enter the open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb. MAIN OUTCOME MEASURES: Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol [EQ] 5-dimensions three-level [EQ-5D-3L]). RESULTS: The open-label extension included 296 treated patients. Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P < .0001). Carer Burden Scale scores also significantly improved from the main period baseline to the end-of-study visit (P < .05 for all caregiving activities except "applying a splint"). At the end-of-study visit, versus the main period baseline, 19.7%-33.3% of patients experienced improvements for each parameter on the EQ-5D-3L, except "mobility," with significant improvement in EQ-5D visual analog scale scores (P < .001). CONCLUSIONS: Repeated incobotulinumtoxinA treatments at 12-week intervals in participants with chronic poststroke upper-limb spasticity resulted in significant improvements in QoL, as well as significant reductions in upper-limb functional disability and caregiver burden. SN - 1934-1563 UR - https://www.unboundmedicine.com/medline/citation/31647185/IncobotulinumtoxinA_Treatment_in_Upper-Limb_Poststroke_Spasticity_in_the_Open-Label_Extension_Period_of_PURE:_Efficacy_in_Passive_Function,_Caregiver_Burden,_and_Quality_of_Life L2 - https://doi.org/10.1002/pmrj.12265 DB - PRIME DP - Unbound Medicine ER -
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